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Food Safety

FDA released a number of guidances Thursday (March 1) providing manufacturers with advice on how to comply with new nutrition labeling requirements related to dietary fiber, added sugar and serving size. Agency Commissioner Scott Gottlieb also announced a new consumer education campaign on nutrition.

The Endocrine Society is disappointed that FDA is holding up preliminary results from a new study as further justification of its previous finding that bisphenol A (BPA) is safe for use in food containers and packaging.

Despite FDA Commissioner Scott Gottlieb’s frequent quips that FDA’s standards of identity for food are the types of regulations FDA can scrap pursuant to President Donald Trump’s deregulatory executive orders, one food lobby is using FDA’s docket on expendable regulations to argue FDA should expand, rather than scrap, certain standards of identity.

The California Farm Bureau Federation is calling for FDA to rewrite all Food Safety Modernization Act (FSMA) rules, but it takes particular issue with the produce safety rule, which the group says unfairly subjects high- and low-risk produce to the same standards and is overly vague.

Consumer groups and private laboratories are waiting with bated breath for FDA to get a Food Safety Modernization Act (FSMA)-mandated lab accreditation program, which would certify private laboratories for analyzing food imports, off the ground.

FDA and the Department of Agriculture finalized an agreement Tuesday (Jan. 30) to formally cooperate on produce safety, biotechnology regulation and oversight of food facilities where they share jurisdiction.

Multiple House Energy & Commerce members invited FDA to ask for more authority to oversee food safety threats after they raised concerns about the HHS Office of Inspector General's findings that the agency continues to fall short in that area, but FDA made it clear that it is not seeking lawmakers' help.

The House Energy & Commerce oversight subcommittee will hold a hearing Friday (Jan. 19) on FDA’s handling of food recalls. The hearing will discuss a recently released report by the HHS Office of Inspector General, which identified key flaws in FDA’s response to food borne outbreaks.

FDA and the Centers for Disease Control and Prevention are under fire for an alleged lack of transparency with the public after the agencies declined to warn consumers that romaine lettuce may be the source of an E. coli outbreak.

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

In response to comments from food industry stakeholders, FDA won’t subject certain entities and activities to some provisions of the Food Safety Modernization Act (FSMA) that pertain to current good manufacturing practices (CGMPs) and risk-based controls for human and animal food; foreign supplier verification; and produce safety standards for growing, harvesting, packing and holding produce intended for humans, the agency explained in guidance document and press announcement on Thursday (Jan. 4).

FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

FDA issued long-awaited guidance answering industry questions about how to comply with its menu labeling rule, slated to go into effect May 7, 2018, but the industry noted it will exercise enforcement discretion for out-of-compliance companies to help them comply with the law.

FDA Monday (Oct. 30) for the first time moved to revoke an FDA-authorized health claim, issuing a proposed rule, which if finalized, would revoke the authorized health claim linking consumption of soy protein to lower risk of heart disease.

FDA's top lawyers argue that the U.S. International Trade Commission should not take up a recent unfair competition case filed by Amarin Pharma asking the commission to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements.